# FDA 483 - Jian Fang - September 22, 2021

Source: https://www.globalkeysolutions.net/records/483/jian-fang/b57d3d2a-a7b5-4e35-980c-f57ec77a5b9a

> FDA 483 for Jian Fang on September 22, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Jian Fang
- Inspection Date: 2021-09-22
- Product Type: drugs
- Office Name: Beijing China District Office
- Summary: An FDA inspection of Jian Feng in Beijing, P.R. China, a clinical investigator, identified significant issues with the maintenance of adequate and accurate case histories. The firm failed to sufficiently document subject eligibility, accurately report adverse events and concomitant medications in electronic case report forms, and consistently submit imaging for review by the Independent Review Committee. These deficiencies indicate a lack of adherence to protocol requirements and robust data integrity practices in clinical investigations.

## Related Officers

- [Marijo B. Kambere](https://www.globalkeysolutions.net/people/marijo-b-kambere/54e010f0-0d56-4b20-b5e2-112e372de58b)

Company: https://www.globalkeysolutions.net/companies/jian-fang/09466c31-a554-4fa3-be05-bde129becaf0

Office: https://www.globalkeysolutions.net/offices/beijing-china-district-office/ef48e02a-2aae-4b30-8893-272da5f8b9d8